Intermittent Versus Continuous Infusion Meropenem in Cystic Fibrosis
Withdrawn before enrolling
Conditions studied: Cystic Fibrosis
In brief
The purpose of this study is to compare the incidence of nausea and vomiting following short intermittent versus prolonged intermittent infusion of meropenem.
Key facts
- Study ID
- NCT02048163
- Run by
- Dayton Children's Hospital
- People needed
- 0
- Starts
- 2013-12-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2016-02-08
Who can join
Age: 7 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Be an admitted patient at Dayton Children's Hospital.
- Between 7 and 21 years of age.
- Have a documented CF diagnosis with one or more of the following clinical features:
- Sweat chloride > 60 mEq/liter as determined by quantitative pilocarpine iontophoresis test (QPIT).
- Two mutations (well characterized) in the cystic fibrosis transmembrane conductive regulator (CTFR) gene.
- Abnormal nasal potential difference.
- Based on Hankinson/NHanes III criteria, are able to elicit an FEV1 > 25% but with < 95% predicted value when admitted.
- Sputum or throat swab specimen positive for P. aeruginosa and have a history of at least one additional sputum culture positive for P. aeruginosa within the last 12 months.
- Are able to perform an acceptable spirometry session (defined as 3 acceptable or usable efforts per ATS/ERS criteria upon admission).
- Have not smoked tobacco within 28 days prior to Visit 1 and agree not to smoke for the duration of the study.
- Are able to and have given written informed consent (if they are adults) or assent in combination with consent of their legal representative(s) (if they are minors) in a manner approved by the Institutional Review Board.
- Patient is experiencing symptoms of CF exacerbation of CF: with any 4 of the following 12 signs or symptoms:
- Change in sputum;
- New or increased hemoptysis;
- Increased cough;
- Increased dyspnea;
- Malaise, fatigue or lethargy;
- Temperature above 38°C;
- Anorexia or weight loss;
- Sinus pain or tenderness;
- Change in sinus discharge;
- Change in physical examination of the chest;
- Decrease in pulmonary function by 10 percent or more from a previously recorded value;
- Radiographic changes indicative of pulmonary infection.
You may not qualify if…
- History of hypersensitivity or intolerance to meropenem.
- History of hypersensitivity or intolerance to granisetron.
- Are pregnant, breastfeeding, or unwilling to practice a highly effective method of birth control or abstinence during participation in the study.
Where it is running
- Dayton Children's Hospital — Dayton, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.